Acute IllnessPhase 4NCT00497393
Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding
A Phase 4 study testing Clinical Decision Unit in people with Acute Illness, run by University of Alberta at 1 site in Canada.
Trial summary
This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Illness
- What is being tested?
- Clinical Decision Unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,217 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only adult patients (>17 years of age) presenting to the University of Alberta Hospital Emergency Department (UAH ED), during the study interval will be included in the evaluation.
Who cannot join
- Direct admits/Pediatric patients.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes.
Read the detailed description
The study will take place over a 6-week period that will be spilt into three-two-week blocks. Using computerized blocks of 2 weeks, days of the week will be randomly allocated so that each day of the week receives one intervention (CDU) and one control day for the study period. The CDU involves transforming an ED bed location to a 6-chair internal waiting room with 2 adjacent beds assigned to act as assessment and treatment locations. Patients will transition between the chair and stretcher to optimize the use of ED space.
- Conditions
- Acute Illness
- Being tested
- Clinical Decision Unit
- Keywords
- Emergency department, administration, overcrowding
- Medical subject headings
- Emergencies, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision UnitBehavioural
a dedicated 2-bed area to see patients and then rotate them back into the waiting room area for labs and diagnostic imaging.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | regular use of the 2-bed areas in the Emergency department Receives: Behavioral: Clinical Decision Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ED length of stay
Measured: in the Emergency Department
Secondary outcomes (3)
Left without being seen (LWBS) rates
Measured: in the Emergency Department
nurse and physician satisfaction
Measured: following Emergency Department shift
ambulance turnaround times (time
Measured: in the Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute IllnessStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Health, Canada
- Investigators
- Michael Bullard, MD, Principal investigator, University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497393
- Sponsor's protocol ID
- B-130607
- Status last verified
- Sep 2008
- First submitted
- 5 Jul 2007
- Last updated
- 12 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding
- ClinicalTrials.gov ID
- NCT00497393
- Acronym / sponsor ID
- B-130607
- Conditions
- Acute Illness
- Keywords
- Emergency department, administration, overcrowding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,217 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Capital Health, Canada
- Study start
- Jul 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes.
Detailed description
The study will take place over a 6-week period that will be spilt into three-two-week blocks. Using computerized blocks of 2 weeks, days of the week will be randomly allocated so that each day of the week receives one intervention (CDU) and one control day for the study period. The CDU involves transforming an ED bed location to a 6-chair internal waiting room with 2 adjacent beds assigned to act as assessment and treatment locations. Patients will transition between the chair and stretcher to optimize the use of ED space.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | Behavioral: Clinical Decision Unitregular use of the 2-bed areas in the Emergency department |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Only adult patients (>17 years of age) presenting to the University of Alberta Hospital Emergency Department (UAH ED), during the study interval will be included in the evaluation.
Key exclusion criteria (1 listed)
- Direct admits/Pediatric patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Unita dedicated 2-bed area to see patients and then rotate them back into the waiting room area for labs and diagnostic imaging. | Behavioural | Control |
Primary outcome
Total ED length of stay
Time frame: in the Emergency Department
3 secondary outcomes
Left without being seen (LWBS) rates
Time frame: in the Emergency Department
nurse and physician satisfaction
Time frame: following Emergency Department shift
ambulance turnaround times (time
Time frame: in the Emergency Department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bullard, MD principal investigator
University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clinical Decision Unit in people with Acute Illness, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total ED length of stay (time frame: in the Emergency Department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2008.